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Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01606709
Recruitment Status : Terminated (Difficult to recruit patients)
First Posted : May 28, 2012
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Information provided by (Responsible Party):
Lawrence Engmann, UConn Health

Brief Summary:

The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.

The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Condition or disease Intervention/treatment Phase
Endometrial Receptivity Ovarian Hyperstimulation Syndrome Drug: GnRH agonist Drug: hCG Phase 4

Detailed Description:

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: A Prospective Comparison of Transcriptional Profiling of Luteal Phase Endometrial Biopsies After Induction of Oocyte Maturation With a Gonadotropin Releasing Hormone (GnRH) Agonist or Human Chorionic Gonadotropins (hCG)
Actual Study Start Date : April 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GnRH agonist trigger
Induction of oocyte maturation with GnRH agonist
Drug: GnRH agonist
GnRH agonist 1mg one dose
Other Names:
  • leuprolide acetate,
  • lupron

Active Comparator: hCG trigger
Induction of oocyte maturation with hCG
Drug: hCG
5,000 IU one dose
Other Name: Pregnyl

Primary Outcome Measures :
  1. Endometrial Gene Expression Profile [ Time Frame: 7 days after trigger of oocyte maturation ]
    Microarray of gene expression in the midluteal phase

Secondary Outcome Measures :
  1. Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger [ Time Frame: At baseline and up to 7 days after trigger of oocyte maturation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Oocyte donors
  • Ages between 21 and 33
  • Normal baseline serum FSH < 10mIU/mL

Exclusion Criteria:

  • Hypothalamic dysfunction
  • Smokers
  • Baseline serum FSH ≥ 10mIU/mL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01606709

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United States, Connecticut
UCHC Division of Reproductive Endocrinology
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
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Principal Investigator: Lawrence Engmann, MD, MRCOG UConn Health
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Responsible Party: Lawrence Engmann, MD, UConn Health Identifier: NCT01606709    
Other Study ID Numbers: 11-168-1
First Posted: May 28, 2012    Key Record Dates
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawrence Engmann, UConn Health:
GnRHa trigger
endometrial gene profile
quality of life
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents